06282017Headline:

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Brandy Miller
Brandy Miller
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Is Transvaginal Mesh worth it?

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Women, who are being treated for Pelvic Organ relapse or Urinary Incontinence, are better off getting the traditional surgery that does not use a mesh.

Transvaginal Mesh was approved for usage by the FDA 510(k) approval Process. This process categorizes medical devises. Class II devises are considered low to moderate risk. Manufactures of class II devises are only required to notify the FDA 90 days before they market them. This means that there is less time for the FDA to conduct studies of these devises before they are made available to the public. What makes it even more dangerous is that if the FDA finds that a potential class II device is substantiality similar to a device already on the market, it does not have to be clinically tested.

In 1996 Boston Scientific came out with the first Transvaginal mesh called ProtoGen Mesh. This first Transvaginal mesh was approved through the 510(k) approval process simply by comparing it to mesh that was available at the time to treat abdominal wall defects and Hernias. The problem with this is that Transvaginal mesh is used is a narrow anatomical area. This makes it more prone to complications.

Two years after the release of the ProtoGen Jonson &Johnson came out with their own Transvaginal mesh. The company claimed that it was substantiality similar to ProtoGen. This allowed their mesh to be approved through the 510(k) process. There are other Transvaginal meshes that are on the market today are based on the ProtoGen design. The problem is that in 1999 ProtoGen was pulled from the market after it was associated with high numbers of complications,

Reports of complications show that Transvaginal mesh create more problems than they solve. The most common serious complications are mesh erosion, Vagina mesh contraction, and organ perforation .Some of these complications requires multiple surgeries to fix. Between 2008 and 2010 nearly 3,000 adverse effects were associated with Transvaginal mesh. In fact there is little evidence that shows the benefits of Transvaginal Mesh were better than traditional surgery. In fact in one of the few published studies on this showed that only after three months patients who had the Transvaginal mesh had mesh erosion in 16 percent of the patients also cure rates and quality of life did not defer significantly between the mesh patients and the non-mesh patients.

If you or any one you know has urinary incontinence or pelvic organ prolapse. You or they should stay far away from Transvaginal mesh as it offers no know benefit over traditional surgery, and has a higher rate of complications over traditional surgery

Written by Eli Lubin